8 results
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28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Meridian Interbody System; WaveForm A Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
FDA 510(k)
FDA Class 2
·Cardiovascular
SHERPA PAK TRANSPORTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 2, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025